Last reviewed · How we verify
NCT05914246
VIOLA Post Market Surveillance Clinical Protocol
NA trial testing VIOLA proximal seal in Coronary Artery Disease in 15 participants. Completed in 16 July 2024.
9 January 2024
Quick facts
| Lead sponsor | Vascular Graft Solutions Ltd. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 15 |
| Start date | 5 July 2023 |
| Primary completion | 9 January 2024 |
| Estimated completion | 16 July 2024 |
| Sites | 1 location across Israel |
Drugs / interventions tested
- VIOLA proximal seal
Conditions studied
- Coronary Artery Disease — all drugs for Coronary Artery Disease →
Sponsor
Vascular Graft Solutions Ltd.
Who can join
18 and older, any sex, with Coronary Artery Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goal of this post marketing surveillance clinical trial is to learn about VIOLA as a proximal seal device in patients undergoing coronary artery grafting (CABG) surgery. The main objective is to evaluate the clinical safety and performance of the VIOLA. Participants will be treated with routine CABG with use of VIOLA for maintaining hemostasis when suturing the proximal anastomosis. Patients will be followed for any clinical events at 6 weeks and 9 months post surgery.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05914246
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Coronary Artery Disease
Currently open trials in the same condition.
- NCT07399002 — LONG NAGOMI™ PMCF STUDY · recruiting
- NCT07420582 — Antegrade Autologous Blood Reinfusion After CPB · recruiting
- NCT07493603 — A Study on Yiyang Huoluo Decoction in the Treatment of Coronary Heart Disease · Phase 1, PHASE2 · recruiting
- NCT06535568 — Single vs. Dual Antiplatelet Therapy in Elderly or HBR Patients Undergoing Percutaneous Intervention With DCB (PICCOLETO · NA · recruiting
- NCT07286578 — A Prospective, Multicenter, Randomized Controlled Trial to Investigate the Value of Coronary CT Angiography in the Under · NA · recruiting
Other Vascular Graft Solutions Ltd. trials
Trials by the same sponsor.
- NCT03209609 — VEST Venous Graft External Support Pivotal Study · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05914246 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Vascular Graft Solutions Ltd.
- Last refreshed: 6 February 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05914246.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing